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TEPEZZA (Amgen Australia Pty Ltd)
Product name
TEPEZZA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
151 (255 working days)
Active ingredients
teprotumumab
Registration type
NCE/ NBE
Indication
TEPEZZA is indicated for the treatment of moderate to severe Thyroid Eye Disease (TED) (see section 5.1 Pharmacodynamic properties – Clinical trials).
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available